Pendulum D2D Glucose Control for Adults With Type 2 Diabetes

The Effect of Pendulum Glucose Control on GI Symptoms and Glycemic Control in Subjects With Type 2 Diabetes

The study is a single site, prospective, open label, observational, single arm trial in 30 patients with type 2 diabetes with GI complaints using 1 or more oral or injectable anti-hyperglycemic agents to investigate if altering the microbiome though Pendulum T2D dietary supplementation can further enhance the efficacy of the current treatment while reducing the GI associated symptoms in patients with Type 2 diabetes.

Study Overview

• Status: Withdrawn
• Conditions: Type2 Diabetes; Gastrointestinal Symptoms
• Intervention / Treatment: Dietary supplement: Pendulum Glucose Control formulation for T2D

Detailed Description

A high prevalence of gastrointestinal (GI) symptoms exist in both type 1 and type 2 diabetes that affect the quality of life negatively and substantially, although the underlying pathophysiology and relationship with glycemic control remain unclear. The current study aims to investigate if altering the microbiome though Pendulum T2D dietary supplementation can further enhance the efficacy of the current treatment while reducing the GI associated symptoms in patients with Type 2 diabetes mellitus who are already on a stable dose of metformin alone and/or alongside other oral or injectable anti-hyperglycemic agents (sulfonylurea agents, DPPIV inhibitor,Glucagon-like peptide (GLP)-1 agonist, sodium-glucose cotransporter (SGLT)-2 inhibitor and/or insulin) and with present GI symptoms. The study is a single site, prospective, open label, observational, single arm trial in 30 patients with type 2 diabetes with GI complaints using 1 or more oral or injectable anti-hyperglycemic agent and an HbA1C between 6.5% and 9.5%. The study will be 8 weeks in duration (2 weeks baseline and 6 weeks product intervention), with an option to continue to 6 months for those willing to continue taking the dietary supplement. As the study is observational and the data are to be used to for the purpose of evaluating improvement in GI symptoms during the intervention with Pendulum T2D there is no specific method to determine sample size.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90211
      • USC Westside Center for Diabetes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Body mass index ≤ 45 kg/m2.
• Subjects with type 2 diabetes that are on a stable dose of one or more injectable or oral antihyperglycemia agents for at least 8 weeks prior to screening.
• HbA1c ≥ 6.5 % and ≤ 9.5% obtained at the screening visit.
• Subjects with any gastrointestinal symptoms including but not limited to heartburn, indigestion, diarrhea, constipation.
• Must be willing and be able to give written informed consent.

Exclusion Criteria:

• Type 1 diabetes
• Pregnant, nursing or planning pregnancy
• Planning elective surgery in the next 8 weeks
• Current or planned use of steroids, orally or injected
• Diagnosis of irritable bowel disease , diverticulitis, other significant GI illness
• Co-existing severe health condition, such as active cancer or unstable cardiovascular disease/congestive heart failure.
• Severe allergy to tape or any component of the CGM device

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Pendulum; Pendulum Glucose Control formulation for T2D will be taken twice daily - 1 capsule with the morning meal and 1 capsule with the evening meal for 8 weeks with an option of continuing up to 6 months.

Dietary supplement: Pendulum Glucose Control formulation for T2D; All bacteria contained in the study product formulation are commensal organisms that have been repeatedly documented to inhabit the human GI tract under normal circumstances. Pendulum's Glucose Control Formulation consists of five human commensal microbial strains including butyrate producing and mucin-degrading strains. The organisms were grown under controlled conditions consistent with Good Manufacturing Practices (GMP) and employ no animal-derived products. All ingredients utilized during manufacturing were food grade and qualified as generally recognized as safe (GRAS). The product is provided as acid-resistant capsules in bottles that are to be stored refrigerated at 4℃.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decreased Gastrointestinal Symptoms	Mean change from baseline in overall Gastrointestinal Symptom Rating Scale (GSRS) scores. The GSRS is a 15-item self-administered questionnaire related to abdominal pain, reflux, indigestion, diarrhea and constipation syndromes, that assesses the impact of gastrointestinal symptoms during the past week on a scale from 1 (no discomfort at all) to 7 (very severe discomfort).	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increased time in glucose range	Measured by continuous glucose monitor (CGM)	6 weeks
Decreased time in hyperglycemic range	Measured by continuous glucose monitor (CGM)	6 weeks
Decreased time in hypoglycemic range	Measured by continuous glucose monitor (CGM)	6 weeks
Improvement in A1C	Point of Care Hemoglobin A1c (HbA1c) %	6 weeks
Improvement in fructosamine level	Blood draw to measure fructosamine	6 weeks
Improvement in A1C	Point of Care Hemoglobin A1c (HbA1c) %	12 weeks
Improvement in A1C	Point of Care Hemoglobin A1c (HbA1c) %	24 weeks

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: Pendulum Therapeutics
• Investigators: Principal Investigator: Anne L Peters, MD, University of Southern California

Study record dates

Study Major Dates

• Study Start (Anticipated): January 15, 2021
• Primary Completion (Anticipated): February 14, 2022
• Study Completion (Anticipated): June 14, 2022

Study Registration Dates

• First Submitted: January 10, 2020
• First Submitted That Met QC Criteria: January 10, 2020
• First Posted (Actual): January 14, 2020

Study Record Updates

• Last Update Posted (Actual): October 7, 2021
• Last Update Submitted That Met QC Criteria: September 29, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: Pendulum D2D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No